Andrositol® TEST as Diagnostic Assay to Predict the Fertilization Potential in IVF

Male Infertility Clinical Trial

Official title:

Andrositol® TEST as Diagnostic Assay to Predict the Fertilization Potential of the Sperm in the in Vitro Fertilization (IVF) Procedures.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677011
• Other study ID #: 100006555
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: October 31, 2021

Study information

• Verified date: April 2022
• Source: Lo.Li.Pharma s.r.l
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Andrositol® test allows to obtain additional information besides the WHO parameters and to evaluate the semen energetic status. The diagnosis is performed by analyzing the semen at two different time points: before the treatment and 30' after the addiction of myo-inositol directly to the semen. The purpose of this study is to evaluate if the responsiveness to the Andrositol® test of a sperm sample can be predictive of its fertilization rate in an ICSI (Intracytoplasmic Sperm Injection) cycle (primary outcome). Secondary outcomes as embryo development, embryo euploidy status and embryo implantation rate will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 249
• Est. completion date: October 31, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• male partners of couples undergoing an egg donor cycles

Exclusion Criteria:

• sperm volume lower than 1 ml

• sperm count lower than 5 X 106 /ml

• total sperm motility lower than 10%

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

Diagnostic Test:
• Andrositol® Test
The intervention consists in the addiction of myo-inositol directly to the semen identifying the quality of sperm prior ICSI procedure

Locations

Country	Name	City	State
United States	HRC Pasadena	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increment of the fertilization rate	measurement of the % oocytes become fertilized by sperm cells. This outcome, is calculated for each patient at day + 1 (14-20h after icsi)	up to 20 hours after ICSI
Secondary	Increment of implantation rate	implantation rate is calculated as the number of gestational sacs observed at echographic screening at +5 weeks of pregnancy divided by the number of embryos transferred	up to 10 days after ICSI
Secondary	embryo development	the number of blastocysts for each patient at day +5, +6, +7	up to 6 days after ICSI
Secondary	embryo euploidy	Embryo euploidy for each patient at day +10	from 10 days after ICSI